Speedier Process Needed to Get Generic Drugs to Market

Americans pay around $1,200 for prescription medication each year, well above patients in Canada, Europe, or Australia. In 2020 alone, Americans spent $358.7 billion on prescription drugs. These high costs force millions to skip doses of life-saving medicines and leave patients facing unnecessarily adverse health outcomes. The Food and Drug Administration (FDA) should seek to lower the amount Americans pay for prescriptions by allowing generic alternatives faster access to the market, while Congress should also act to prohibit practices that intentionally prevent competition.

Generic drugs are similar to brand name drugs in quality, strength, safety, performance, and function but cost between 80 to 85% less. However, rather than creating a fast and efficient process for getting generics to the patients, the FDA requires these drugs go through the Abbreviated New Drug Approval (ANDA) process, which can take ten months to complete. Such a long and unnecessary approval process hurts consumers by denying them timely access to cheaper alternatives.

The FDA’s ANDA approval process also creates significant leverage for brand name drug manufacturers to impede the approval process for generic drugs. To comply with ANDA, generic manufacturers must have access to undisclosed data from the brand name competitors.

Generic manufacturers must also demonstrate that their product performs the same way as the brand name drug. One way to prove this is for generic manufacturers to use preclinical and clinical data from the brand name manufacturers to verify that the generic drug has the same active ingredient, formulation, strength, and instructions.

According to the American Medical Association, brand name manufacturers regularly deny generic manufacturers access to drug samples and data necessary for bio-equivalence testing. By blocking access to data, brand name manufacturers stop generic manufacturers from satisfying ANDA and ultimately getting their products to patients.

In 2019, the FDA published a list of forty-one branded drug manufacturers that have blocked access to necessary data in an attempt to impede the approval process for generic drugs. Brand name manufacturers blocked data for various drugs such as blood thinners, pain killers, cancer-treating medications, and other serious diseases.

Pharmaceutical manufacturers have also used secondary patents to delay generics’ entry into the market. Secondary patents protect pharmaceutical manufacturers’ intellectual property, such as drug delivery methods and active ingredients. By placing a secondary patent on any aspect of a brand name drug, pharmaceutical manufacturers have significant leverage to block generic manufacturers from bringing their products to market.

For example, two Human Immunodeficiency Virus (HIV) medications, Ritonavir, and Lopinavir have a combined 108 patents preventing generic alternatives from being manufactured. By blocking generic manufacturers access to data, pharmaceutical companies are impeding entry into the market and forcing consumers to pay more.

In addition, Medicare not getting enough generics on its formulary – the menu of drugs covered on the plan. This means for Medicare costs and higher taxpayer obligations. That is a huge problem and it is time to modernize Medicare Part D to permit cheaper drugs to available to patients. Generic drugs provide consumers with safe and effective alternatives that will also lower their prescription costs.

The FDA should reassess its rigorous approval process for generic drugs that not only needlessly delay the entry of generic drugs but also grants unprecedented power to brand name manufacturers. Additionally, the U.S. Congress should seek to prohibit pay for delay agreements and secondary patents that deny patients access to cheaper alternatives. Doing so will ultimately ensure patients are given greater access to potentially life-saving medications.

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